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EUDAMED last updated this device on Aug 15, 2023
B-04015672109681NEB6001 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by 3A HEALTH CARE S.r.l.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
04015672109681B-04015672109681NEB6001(01)04015672109681
European Medical Device Nomenclature — the EU product classification assigned to this device.
R060101COLD NEBULISATION SYSTEMSNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Netherlands; available across 16 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Jan 1, 2023 | Jan 1, 2028 |
| Belgium | Jan 1, 2023 | Jan 1, 2028 |
| Bulgaria | Jan 1, 2023 | Jan 1, 2028 |
| Czechia | Jan 1, 2023 | Jan 1, 2028 |
| Germany | Jan 1, 2023 | Jan 1, 2028 |
| Estonia | Jan 1, 2023 | Jan 1, 2028 |
| Spain | Jan 1, 2023 | Jan 1, 2028 |
| France | Jan 1, 2023 | Jan 1, 2028 |
| Hungary | Jan 1, 2023 | Jan 1, 2028 |
| Italy | Jan 1, 2023 | Jan 1, 2028 |
| Lithuania | Jan 1, 2023 | Jan 1, 2028 |
| Latvia | Jan 1, 2023 | Jan 1, 2028 |
| Poland | Jan 1, 2023 | Jan 1, 2028 |
| Romania | Jan 1, 2023 | Jan 1, 2028 |
| Slovakia | Jan 1, 2023 | Jan 1, 2028 |
| XI | Jan 1, 2023 | Jan 1, 2028 |
IT-MF-000009298No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.1947